NeXstar Pharmaceuticals announced that a team of independent investigators has reported the findings of a phase II study in which DaunoXome (liposomal daunorubicin(Drug information on daunorubicin) citrate for injection) was evaluated as a treatment for low- and intermediate-grade non-Hodgkin's lymphoma (NHL). The data, presented November 7, 1996, at the 16th Chemotherapy Foundation Symposium in New York City, included 14 patients whose disease was resistant to conventional chemotherapy or who had relapsed after prior therapy. DaunoXome is NeXstar's proprietary liposomal formulation of the anthracycline chemotherapy agent daunorubicin.
Patients included in this study received 100 mg/m² of DaunoXome every 3 weeks. Of the 14 patients treated, 11 (79%) had stage IV disease with bone marrow involvement. Eight patients (57%) had not responded to two or more prior chemotherapy regimens, and the remaining six had failed to respond to one prior regimen. The data were presented by Anil Tulpule, md, assistant professor of clinical medicine in the Division of Hematology at the University of Southern California School of Medicine. Dr. Tulpule is coprincipal investigator of this study.
Dr. Tulpule stated that following treatment with DaunoXome, six patients (43%) had a partial response, defined as a greater than 50% reduction in tumor mass. Three of these patients had received prior anthracycline chemotherapy. An additional three patients (21%) achieved stable disease status, defined as stable tumor mass or an increase in existing disease without the appearance of any new lesions. Of these patients, one had received previous anthracycline therapy. Two of the five patients who did not respond died of their disease before receiving a second cycle of therapy but were included in the intention-to-treat analysis.
Dr. Tulpule also stated that "there were no grade 3 or grade 4 non-hematological toxicities, and though there were some instances of grade 3 or grade 4 neutropenia, none of was long-lasting." Dr. Tulpule also stated that, "to date, none of the patients showing response or stable disease have started progressing."
Other sites participating in this ongoing study include Northwest Kaiser Permanente in Portland, Oregon; North Shore University Hospital in Manhasset, New York; Scripps Memorial Hospital in La Jolla, California; Northwestern University Medical School in Chicago; and the Denver Medical Health Center.
DaunoXome is currently approved as a primary therapy for advanced HIV-associated Kaposi's sarcoma in the United States, Canada, and 13 European countries. NeXstar is currently conducting clinical trials in NHL and various other forms of cancer, including breast cancer, glioma and HIV-associated lymphoma.